Title:
DELIVERY DEVICES
Kind Code:
A1


Abstract:
A delivery device for delivering a metered amount of substance (L) in response to exhalation by a user, the delivery device comprising: a mouthpiece (5) through which the user in use exhales; an outlet (45) from which substance Is delivered; and a dispensing unit (35) which is operable to dispense a metered amount of substance through the outlet in response to exhalation by the user through the mouthpiece, wherein the dispensing unit comprises a body member (37) which includes a cavity (39) for containing a metered amount of substance, an outlet nozzle (43) which is fluidly connected to the cavity from which substance is in use delivered, and a dispensing (41) member which is movably disposed in the cavity and configured to be driven through the cavity by a driving pressure created by exhalation of the user, such as to cause substance to be delivered from the outlet nozzle.



Inventors:
Djupesland, Per Gisle (Oslo, NO)
Application Number:
12/516401
Publication Date:
02/03/2011
Filing Date:
11/28/2007
Assignee:
OPTINOSE AS (Oslo, NO)
Primary Class:
International Classes:
A61M11/00
View Patent Images:
Related US Applications:



Foreign References:
WO2003084591A12003-10-16
Primary Examiner:
STUART, COLIN W
Attorney, Agent or Firm:
PROSKAUER ROSE LLP (One International Place, Boston, MA, 02110, US)
Claims:
1. A delivery device for delivering a metered amount of substance in response to exhalation by a user, the delivery device comprising: a mouthpiece through which the user in use exhales; an outlet from which substance is delivered; and a dispensing unit which is operable to dispense a metered amount of substance through the outlet in response to exhalation by the user through the mouthpiece, wherein the dispensing unit comprises a body member which includes a cavity for containing a metered amount of substance, an outlet nozzle which is fluidly connected to the cavity from which substance is in use delivered, and a dispensing member which is movably disposed in the cavity and configured to be driven through the cavity by a driving pressure created by exhalation of the user, such as to cause substance to be delivered from the outlet nozzle.

2. The delivery device of claim 1, wherein the cavity is an elongate cavity.

3. The delivery device of claim 2, wherein the cavity has a cylindrical section and the dispensing member comprises a ball which is moved along the cavity by the driving pressure created by exhalation of the user.

4. The delivery device of claim 3, wherein the ball sealingly engages with an inner peripheral wall of the cavity.

5. The delivery device of claim 1, wherein the cavity and the dispensing member are configured to provide for movement of the dispensing member at a driving pressure of less than about 5 kPa, and optionally less than about 3 kPa.

6. The delivery device of claim 1, wherein the outlet nozzle provides for an aerosol spray.

7. The delivery device of claim 6, wherein the outlet nozzle provides for a substantially rectilinear flow for a distance of at least about 15 mm, optionally at least about 20 mm, optionally at least about 25 mm and optionally at least about 30 mm from exit of the outlet nozzle.

8. The delivery device of claim 1, wherein the outlet nozzle provides for a jet.

9. The delivery device of claim 1, further comprising: a pressure regulator which is fluidly connected to the dispensing unit, such as to provide for application of a predeterminable driving pressure to the dispensing member.

10. The delivery device of claim 1, wherein the mouthpiece and the outlet are fluidly connected, such as to provide for an air flow through the outlet on exhalation by the user through the mouthpiece.

11. The delivery device of claim 10, further comprising: a housing in which the dispensing unit is disposed and to which the mouthpiece and the nosepiece are fluidly connected, such as to define a fluid communication path therebetween.

12. The delivery device of claim 11, further comprising: a baffle member which is disposed in the fluid communication path.

13. The delivery device of claim 12, wherein the baffle member includes a first, driving air pressure channel which is fluidly connected to the dispensing unit and at which the driving pressure is created on exhalation by the user to actuate the dispensing unit, and at least one second, entraining air flow channel through which an entraining air flow is delivered for entraining substance as delivered by the dispensing unit, optionally the baffle member includes a plurality of entraining air flow channels.

14. (canceled)

15. The delivery device of claim 12, wherein the housing includes an inlet chamber upstream of the baffle member which flares outwardly from the mouthpiece.

16. The delivery device of claim 12, wherein the housing includes an outlet chamber downstream of the baffle member, optionally the outlet chamber surrounds the dispensing unit.

17. (canceled)

18. The delivery device of claim 10, wherein the outlet includes a flow restrictor for providing a flow restriction thereat.

19. The delivery device of claim 18, wherein the flow restrictor tapers inwardly in a flow direction from the mouthpiece to the nosepiece, optionally the flow restrictor has a frusto-conical section.

20. (canceled)

21. The delivery device of claim 10, further comprising: a flow regulator which is disposed at the outlet nozzle of the dispensing unit, optionally the flow regulator includes a plurality of flow apertures which are located on an annulus surrounding the outlet nozzle.

22. (canceled)

23. The delivery device of claim 1, where configured to deliver a liquid.

24. The delivery device of claim 1, wherein the outlet is a nosepiece and the delivery device is a nasal delivery device for delivering substance to a nasal airway of a subject.

25. (canceled)

Description:

The present invention relates to a delivery device for and method of delivering a metered volume of substance, in particular a delivery device for delivering a metered volume of a liquid substance to a nasal cavity of a subject.

Very many delivery devices exist for the delivery of liquid substances, which typically comprise a manually-actuated pump for the delivery of a liquid substance as an aerosol spray.

Whilst these delivery devices have found extensive application, the present inventors have recognized the need for a delivery device which utilizes the exhalation breath of a user as the driving force to deliver a metered dose of a liquid substance.

In one aspect the present invention provides a delivery device for delivering a metered amount of substance in response to exhalation by a user, the delivery device comprising: a mouthpiece through which the user in use exhales; an outlet from which substance is delivered; and a dispensing unit which is operable to dispense a metered amount of substance through the outlet in response to exhalation by the user through the mouthpiece, wherein the dispensing unit comprises a body member which includes a cavity for containing a metered amount of substance, an outlet nozzle which is fluidly connected to the cavity from which substance is in use delivered, and a dispensing member which is movably disposed in the cavity and configured to be driven through the cavity by a driving pressure created by exhalation of the user, such as to cause substance to be delivered from the outlet nozzle.

In one embodiment the cavity is an elongate cavity.

In one embodiment the cavity has a cylindrical section and the dispensing member comprises a ball which is moved along the cavity by the driving pressure created by exhalation of the user.

In one embodiment the ball sealingly engages with an inner peripheral wall of the cavity.

In one embodiment the cavity and the dispensing member are configured to provide for movement of the dispensing member at a driving pressure of less than about 5 kPa, and preferably less than about 3 kPa.

In one embodiment the outlet nozzle provides for an aerosol spray.

In one embodiment the outlet nozzle provides for a substantially rectilinear flow for a distance of at least about 15 mm, preferably at least about 20 mm, more preferably at least about 25 mm and yet more preferably at least about 30 mm from exit of the outlet nozzle.

In another embodiment the outlet nozzle provides for a jet.

In one embodiment the delivery device further comprises: a pressure regulator which is fluidly connected to the dispensing unit, such as to provide for application of a predeterminable driving pressure to the dispensing member.

In one embodiment the mouthpiece and the outlet are fluidly connected, such as to provide for an air flow through the outlet on exhalation by the user through the mouthpiece.

In one embodiment the delivery device further comprises: a housing in which the dispensing unit is disposed and to which the mouthpiece and the nosepiece are fluidly connected, such as to define a fluid communication path therebetween.

In one embodiment the delivery device further comprises: a baffle member which is disposed in the fluid communication path.

In one embodiment the baffle member includes a first, driving air pressure channel which is fluidly connected to the dispensing unit and at which the driving pressure is created on exhalation by the user to actuate the dispensing unit, and at least one second, entraining air flow channel through which an entraining air flow is delivered for entraining substance as delivered by the dispensing unit.

In one embodiment the baffle member includes a plurality of entraining air flow channels.

In one embodiment the housing includes an inlet chamber upstream of the baffle member which flares outwardly from the mouthpiece.

In one embodiment the housing includes an outlet chamber downstream of the baffle member.

In one embodiment the outlet chamber surrounds the dispensing unit.

In one embodiment the outlet includes a flow restrictor for providing a flow restriction thereat.

In one embodiment the flow restrictor tapers inwardly in a flow direction from the mouthpiece to the nosepiece.

In one embodiment the flow restrictor has a frusto-conical section.

In one embodiment the delivery device further comprises: a flow regulator which is disposed at the outlet nozzle of the dispensing unit.

In one embodiment the flow regulator includes a plurality of flow apertures which are located on an annulus surrounding the outlet nozzle.

In one embodiment the delivery device is configured to deliver a liquid.

In one embodiment the outlet is a nosepiece and the delivery device is a nasal delivery device for delivering substance to a nasal airway of a subject.

A preferred embodiment of the present invention will now be described hereinbelow by way of example only with reference to the accompanying drawings, in which:

FIG. 1 illustrates a part-sectional perspective view of a delivery device in accordance with a preferred embodiment of the present invention;

FIG. 2 illustrates a longitudinal sectional view of the delivery device of FIG. 1, where in the rest or non-actuated state;

FIGS. 3(a) to (c) illustrate three delivery profiles for the delivered substance obtainable by the delivery device of FIG. 1;

FIG. 4 illustrates the delivery device of FIG. 1, where in the actuated state;

FIG. 5 illustrates a part-sectional perspective view of a delivery device as a modification of the delivery device of FIG. 1; and

FIG. 6 illustrates a longitudinal sectional view of the delivery device of FIG. 5.

The delivery device comprises a first, inlet housing part 3 which defines a mouthpiece 5 at one, inlet end thereof and an inlet chamber 7 which is in fluid communication with the mouthpiece 5 and the other, outlet end of which is open, such that exhalation by a user into the mouthpiece 5 delivers an air flow into the inlet chamber 7 and to the open, outlet end thereof.

In this embodiment the mouthpiece 5 comprises a tubular section which is gripped in the lips of the user.

In this embodiment the inlet chamber 7 flares outwardly from the mouthpiece 5, here having a frusto-conical section.

The delivery device further comprises a baffle member 11 which sealingly engages the open, outlet end of the inlet chamber 7, such as to direct the air flow as delivered through the inlet chamber 7.

The baffle member 11 includes a first, driving air pressure channel 21 at which a driving pressure is created, which acts to drive a liquid dispensing unit 35, as will be described in more detail hereinbelow, and at least one, in this embodiment a plurality of second, entraining air flow channels 23 through which an entraining air flow F is delivered.

In this embodiment the first, driving air pressure channel 21 is located on the longitudinal axis of the inlet chamber 7. In this embodiment the driving air pressure channel 21 has a circular section, here having a diameter of at or less than about 6 mm.

In this embodiment the entraining air flow channels 23 are located such as to be in fluid communication with the periphery of the open, outlet end of the inlet chamber 7. In this embodiment the baffle member 11 includes four entraining air flow channels 23 which are disposed uniformly on an annulus about the longitudinal axis of the inlet housing part 3, and each have a circular section, here having a diameter of at or less than about 4 mm.

In this embodiment the baffle member 11 comprises first and second baffle elements 25, 27, here plates which are disposed in juxtaposed relation.

The delivery device further comprises a pressure regulator 29 which includes an aperture 31 which is fluidly connected to the driving air pressure channel 21 in the baffle member 11, in this embodiment at the downstream end thereof, such as to provide for the generation of a predetermined pressure thereat. In this embodiment the aperture 31 has a circular section, here having a diameter of at or less than about 4 mm.

The delivery device further comprises a liquid dispensing unit 35 which is fluidly connected to the pressure regulator 29 such as to be actuated by the driving air pressure P as generated on exhalation by the user through the mouthpiece 5.

The liquid dispensing unit 35 comprises a body member 37, in this embodiment a tubular member, here of cylindrical section, which defines an elongate cavity 39 which contains a metered dose of a liquid L, a dispensing member 41 which is movably disposed in the cavity 39, such as to be moved along the cavity 39 under the action of the driving air pressure P and thereby dispense the liquid L from the cavity 39, and an outlet nozzle 43 which is configured to provide for dispensing of the liquid L at a predetermined rate.

In this embodiment the cavity 39 has a volume of about 1 ml. In another embodiment the cavity 39 could have a volume of or less than about 200 μl.

In this embodiment the dispensing member 41 is initially disposed at one end of the cavity 39 adjacent the flow regulator 29 and is moved to the other end of the cavity 39 under the action of the driving air pressure, with the liquid L as contained in the cavity 39 being progressively dispensed as the dispensing member 41 is moved along the cavity 39.

In this embodiment the dispensing member 41 and the cavity 39 of the liquid dispensing unit 35 are configured to provide for movement with a driving air pressure P at or less than about 5 kPa and preferably at or less than about 3 kPa.

In this embodiment the dispensing member 41 is a ball which sealingly engages the peripheral wall of the cavity 39.

The outlet nozzle 43 includes an outlet orifice 45 which is shaped and dimensioned, in this embodiment having a circular section, to provide the dispensed liquid with a predetermined profile. In this embodiment the outlet orifice 45 is configured to dispense the liquid L such that the flow of liquid L remains substantially rectilinear for a distance of at least about 15 mm, preferably at least about 20 mm, more preferably at least about 25 mm and yet more preferably at least about 30 mm from the exit of the outlet orifice 45 and thereafter provide a dispersed aerosol spray, as illustrated in FIG. 3(a). In an alternative embodiment the outlet orifice 45 can be configured to provide a liquid jet, either with some dispersion in the form of a shower of droplets, as illustrated in FIG. 3(b), or with no dispersion, as illustrated in FIG. 3(c).

In preferred embodiments the outlet orifice 45 has a diameter of at or less than about 3 mm, preferably at or less than about 2 mm, and more preferably at or less than about 1 mm.

In this embodiment the outlet nozzle 43 includes a frangible membrane which normally encloses the outlet orifice 45 thereof such as to contain the liquid L and is ruptured on the application of the driving air pressure P to the liquid L.

The delivery device further comprises a second, outlet housing part 51 which defines a nosepiece 53 at one, outlet end thereof and an outlet chamber 57, in this embodiment an annular chamber surrounding the body member 37 of the liquid dispensing unit 35, which is in fluid communication with the entraining air flow channels 23 in the baffle member 11 and opens to an outlet end thereof, such that exhalation by a user into the mouthpiece 5 delivers an entraining air flow F into the outlet chamber 57 and to the open, outlet end thereof.

The delivery device further comprises a flow regulator 61 which encloses the annular outlet chamber 57 at the outlet end of the body member 37 of the liquid dispensing unit 35.

In this embodiment the flow regulator 61 includes a plurality of flow apertures 63, in this embodiment sixteen apertures, which are located on an annulus surrounding the body member 37 of the liquid dispensing unit 35, such as to provide for the delivery of a substantially annular entraining air flow F which entrains the liquid L as dispensed from the liquid-containing cavity 39 of the liquid dispensing unit 35.

In this embodiment the flow regulator 61 is configured to provide for a flow rate of at least about 20 l/min, more preferably at least about 30 l/min, still more preferably at least about 40 l/min and yet more preferably at least about 50 l/min.

In this embodiment the flow apertures 63 have a circular section, here of a diameter of at or less than about 1 mm.

Operation of the above-described delivery device will now be described hereinbelow with reference to FIG. 4 of the accompanying drawings.

A user first inserts the nosepiece 53 into one of his/her nostrils and then grips the mouthpiece 5 in his/her lips. It should be understood that, for the sake of ease of illustration, the delivery device has been illustrated in an elongate configuration where the nosepiece 53 and the mouthpiece 5 are located on a common axis. In practice, the nosepiece 53 and the mouthpiece 5 would be inclined relative to one another, such as to facilitate fitting of the nosepiece 53 and the mouthpiece 5 in respective ones of a nostril and the lips.

The user then exhales through the mouthpiece 5, which is in fluid communication with the inlet chamber 7.

This exhalation acts to generate a driving air pressure P at the driving air pressure channel 21 in the baffle member 11 and an entraining air flow F through the entraining air flow channels 23 in the baffle member 11, which entraining air flow F continues through the outlet chamber 57 and the flow apertures 63 in the entraining air flow regulator 61, which define a substantially annular entraining air flow F which surrounds the outlet end of the liquid dispensing unit 35.

The driving air pressure P as created at the driving air pressure channel 21 simultaneously acts on the dispensing member 41, which is located in the cavity 39 of the liquid dispensing unit 35, such as to move the same along the cavity 39 and dispense the liquid L as contained therein from the outlet end thereof into the entraining air flow F, which surrounds the same, thereby providing for delivery of the liquid L, in this embodiment into the nasal cavity of the user.

In this embodiment the delivery device, in providing for the delivery of the liquid L in an entraining air flow F, advantageously provides for delivery into and through the nasal airway in the manner as described in the applicant's earlier WO-A-2000/051672, the content of which is herein incorporated by reference.

Finally, it will be understood that the present invention has been described in its preferred embodiment and can be modified in many different ways without departing from the scope of the invention as defined by the appended claims.

In one modification, as illustrated in FIGS. 5 and 6, the delivery device can further comprise a flow restrictor 71 at the outlet end of the outlet housing part 51 which defines the nosepiece 53. In this embodiment the flow restrictor 71 tapers inwardly, here with a frusto-conical section 73, towards the outlet end of the outlet housing part 51. In this embodiment the flow restrictor 71 defines an outlet which has a circular section. In preferred embodiments the outlet of the flow restrictor 71 has a diameter of at or less than about 8 mm, preferably at or less than about 6 mm and more preferably at or less than about 4 mm, and the angle of the tapering section 73 of the flow restrictor 71 has an angle of at or less than about 60 degrees, preferably at or less than about 55 degrees and more preferably at or less than about 52 degrees relative to a plane perpendicular to the longitudinal axis of the outlet housing part 51. With this configuration, a faster delivery of the liquid L can be achieved as compared to the above-described embodiment.